Introduction to risk management: basic concepts, definitions, and the significance of risk management within the framework of EN ISO 15189
Risk management within the management system: operational and financial risks
Key requirements of EN ISO 22367: presentation of the general risk management process, management responsibilities, planning, identification, analysis, evaluation, and risk control
Implementation and evaluation of risk control: control measures, verification, the role of standards and IVD medical devices, residual risk evaluation, and benefit-risk analysis
Review and monitoring of risk management: completeness of control, evaluation of overall residual risk, reporting, and risk monitoring, analysis, and control activities (internal – external information sources, immediate actions)
Review of informative annexes of EN ISO 22367: indicative examples of safety-related characteristics identification, hazards, foreseeable sequences of events, hazardous situations, risk analysis tools and techniques, assessment methods, and overall residual risk evaluation
